What made you go WTF today?

[Steely Glint]

http://www.theverge.com/2016/8/23/12...terstitial-ads

Dear the entire Internet Marketing industry,

WHERE IS YOUR GOD NOW, BITCHES

[Nessus]

WHERE IS YOUR GOD NOW, BITCHES

No gods

No kings

ONLY MAN

[wiggin]

I just learned that the first bioresorbable stent got CE Mark in Europe in 2011, based on nearly nonexistent clinical efficacy data. That's crazy - the FDA only gave the first approval this summer and based on the latest clinical data that just came out they are reconsidering the whole thing. I can't imagine how many thousands of patients have had substandard stents implanted in them because regulators were way too permissive. For that matter, I'm still confused why anyone thought current designs were a good idea in the first place.

[Flixy]

Which one is that? I'm interested and sure people at my work know about it.

We're also working on CE approval (and FDA in parallel) and it's not easy to get.

[wiggin]

Which one is that? I'm interested and sure people at my work know about it.

We're also working on CE approval (and FDA in parallel) and it's not easy to get.

ABSORB is the name of the product; it is made by Abbott. New clinical data just came out in the last few weeks that casts yet more doubt on the efficacy and safety of the stent compared to the newest metal drug-eluting stents.

CE Mark is not easy to get, but in general the requirements are laxer than for the FDA - the FDA requires bigger, better clinical studies with longer timepoints (typically companies will get approval in Europe first and use data from the European roll-out to get FDA approval). There are exceptions, though, since each class of devices and drugs is regulated differently and there are some faster tracks available at the FDA. The clinical data available when this product got the CE Mark was just ridiculously small sample size and short term follow up. Given that the current gold standard treatment was pretty damned good (this was a non-inferiority design rather than a superiority design) there was no reason to fast-track approval for something so new and with so many serious questions about how it would work in the long term clinically. In this particular case, IMO it borders on negligence.

The FDA is sometimes to restrictive and cautious, and that is incredibly frustrating (and drives up costs). But we've seen far too many times that their caution is warranted when new classes of therapies come out and end up performing quite poorly.

[GGT]

ABSORB is the name of the product; it is made by Abbott. New clinical data just came out in the last few weeks that casts yet more doubt on the efficacy and safety of the stent compared to the newest metal drug-eluting stents.

CE Mark is not easy to get, but in general the requirements are laxer than for the FDA - the FDA requires bigger, better clinical studies with longer timepoints (typically companies will get approval in Europe first and use data from the European roll-out to get FDA approval). There are exceptions, though, since each class of devices and drugs is regulated differently and there are some faster tracks available at the FDA. The clinical data available when this product got the CE Mark was just ridiculously small sample size and short term follow up. Given that the current gold standard treatment was pretty damned good (this was a non-inferiority design rather than a superiority design) there was no reason to fast-track approval for something so new and with so many serious questions about how it would work in the long term clinically. In this particular case, IMO it borders on negligence.

The FDA is sometimes to restrictive and cautious, and that is incredibly frustrating (and drives up costs). But we've seen far too many times that their caution is warranted when new classes of therapies come out and end up performing quite poorly.

Maybe it's because I'm busy getting drunk .....but that sounds just like the 2016 US Presidential election, where people are asking How the Hell did the results stray so far from 'the gold standard' of predictive models? Small sample sizes, bad data, aggregate data, questions about short-term vs long-term effects, unknown effects from fast-tracking, political strategy negligence, etc.

In the end, I think it boils down to money, and if SICI (that's my acronym for systemically important civic institutions) can compete against SIFI (systemically important financial institutions) for government funding, using tax dollars. Research is important and valuable, but it shouldn't be relegated to "freee market capitalism". The US Space program got us to the moon in the first place.

[Aimless]

Today I learned that there used to be a primal scream room at our psych clinic. It was used for primal scream therapy but this practice was discontinued a while back. I expect this was because it was constantly occupied by frustrated staff and thus unavailable to patients

[Loki]

Florida woman.

http://www.bbc.com/news/world-us-canada-38080181

[Hazir]

Today I came accross a piece that dealt with a news story I had seen a headline of only hours before. It's that story of the founder of Corona beer leaving his estate to the inhabitants of the village in Spain where he was born. Turns out he did no such thing, despite the 'news' bouncing around over the internet, including on presumably reputable news-sites. The man actually left his estate to his extended family, some of whom lived in said village, part-time. The villagers on the other hand were benefitting from his generosity while he was still alive.

How fucked up is that?

[Echovirus]

Just like that whole fake news bit about CNN showing hardcore porn for a half hour on Thanksgiving night. One person was tweeting about it, not even multiple people, and yet everywhere ran with that stupid story.

[Echovirus]

Yet another Florida woman. *headdesk*

http://www.whio.com/news/national/fl...NXtm7Z7njedEL/

[Hazir]

Church collapses in Kenya and CNN has a report phoned in from Johannesburg.

[Aimless]

Church collapses in Kenya and CNN has a report phoned in from Johannesburg.

"Africa-correspondent"

[Loki]

Ditto. That's probably their only remaining correspondent I'm Africa. This is a major issue in journalism.

[Aimless]

http://venturebeat.com/2016/08/14/re...ortcut-chrome/

[Aimless]

Is this fake news?

[Echovirus]

Unfortunately not.

http://www.cnn.com/2017/01/03/politi...re-resolution/

[Aimless]

No I mean the part about not knowing that Obamacare = ACA

[Echovirus]

Oh, there are definitely people like that. And rather sad to say that I'm even related to more than a handful of such people.

[Ominous Gamer]

The states won by Trump have the highest Obamacare enrollment. We have more than a few "dense motherfuckers" in this country.

[Loki]

https://mobile.twitter.com/svonewsle...12767523565570

[Aimless]

https://soundcloud.com/vagidictoris/...notes-are-in-c

[Aimless]

http://www.vox.com/identities/2017/3...ves-immigrants

Ben Carson is for reals the weirdest person in US politics.

[Loki]

http://www.businessinsider.com/nude-...scandal-2017-3

[Ominous Gamer]

https://heatst.com/tech/he-will-not-...y-to-troll-it/

Weaponized Autism

[Lewkowski]

https://heatst.com/tech/he-will-not-...y-to-troll-it/

Weaponized Autism

Kinda crazy.

[Loki]

And youth unemployment, as the author aptly pointed out.

[RandBlade]

For my Italian Restaurant as marketing I regularly take photos of the food and post them on Facebook and Twitter. Today I posted a collage of four meals with a caption of their names but after I posted it, Facebook decided when showing it to me to "translate it to English" which was gibberish. It was translated from Italian. Except the names are correctly in Italian and what they should be called in English. Plus it was capitalised as a proper noun.

I don't want all my customers who follow the restaurant to see gibberish English translations of names of meals that's dumb. Even if the translations were accurate it would still be improper to translate them, you don't translate names.

[Aimless]

That'll teach you to put Spaghetti alla puttanesca on the menu

[Flixy]

That'll teach you to put Spaghetti alla puttanesca on the menu

I must say that sometimes it does get a bit silly when all dinners are called exactly what's in there except in Italian to make it sounds nicer. Up to a point it's nice but some places push it a bit too far